DeepSparseCBCT for Low Dose Lung CBCT Reconstruction

Not Applicable

Recruiting

• Conditions: Lung Nodules

• Registration Number: NCT07035977
• Lead Sponsor: Wuhan Union Hospital, China

Brief Summary

The goal of this clinical trial is to learn if the DeepSparseCBCT model ensure high-quality CBCT image while reducing CBCT radiation dose. The main questions it aims to answer are:

* Can DeepSparseCBCT reduce CBCT radiation doses?

* Is the image quality of DeepSparseCBCT reconstruction consistent with that of existing clinical reconstruction method? Researchers will compare CBCT images quality reconstruction with DeepSparseCBCT model to CBCT image quality reconstruction with existing clinical protocols to see if DeepSparseCBCT model can improve the CBCT image quality while reducing radiation dose.

Participants will:

* Receive a single low dose (1/6 of existing clinical protocols) CBCT scan

* Receive a single conventional dose CBCT scan

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-15
• Status Verified: 2025-06
• Primary Completion: 2025-06-15
• Study First Submitted: 2025-06-17
• Study First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Study Completion: 2025-06-20
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Type of examination: Participants will receive percutaneous lung biopsy under the guideline of Cone Beam CT (CBCT) during the study period.
• Completeness of information: Medical records containing basic information, medical history, etc.
• Informed consent: written consent form signed by the patient or legal representative.

Exclusion Criteria

• Patients under the age of 18.
• Mental cognitive problems: suffering from severe mental illness or cognitive impairment, unable to understand the study and sign.
• Pregnant: Fetus is radiosensitive and physiological changes during pregnancy affect the images.
• Participation in other studies: concurrent participation in other programs that affect the results of this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
CBCT Images Quality Score	No more than 1 week	CBCT Images Quality Score was analyzed by 25 interventionalists using 5-point Likert scale.

Secondary Outcome Measures

Name	Time	Method
Agreement score	No more than 1 week	25 interventionalists from 5 medical centers will be invited to analyze fully sampled machine-reconstructed CBCT images vs. undersampled model-reconstructed CBCT images. The scores given by the 25 interventionalists will be used for agreement score analysis.

Trial Locations

Locations (3)

Wuhan Union Hospital; 🇨🇳 Wuhan, Hubei, China

Wuhan Union Jinyin Lake Hospital; 🇨🇳 Wuhan, Hubei, China

Wuhan Union West Hospital; 🇨🇳 Wuhan, Hubei, China